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    K Number
    K944866
    Device Name
    VIASPAN (BELZER UW - CSS)
    Manufacturer
    THE DUPONT MERCK PHARMACEUTICAL CO.
    Date Cleared
    1996-04-22

    (567 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K020924,K043461,K073693,K091656,K143054,K992209
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Belzer UW Cold Storage Solution preserves organs, by cold storage, just as well as currently marketed media, such as Collins' solution. Belzer UW Cold Storage Solution, hereafter known as BELZER UW-CSS, can be used for cold storage of the liver, pancreas, and kidney. BELZER UW-CSS has the potential to be used as a general solution for most organs, both for initial cooling during in situ donor organ flushing and for subsequent cold storage.

    Device Description

    Not Found

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Device: BELZER UW Cold Storage Solution (BELZER UW-CSS)
    Purpose: Preservation of organs (liver, pancreas, kidney) by cold storage for transplantation.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by demonstrating equivalence or superiority to existing solutions (Collins' or EuroCollins' Solution - ECS) in terms of preservation time and post-transplant organ function.

    OrganAcceptance Criteria (Implicit)Reported BELZER UW-CSS Performance
    KidneyEquivalence/superiority to ECS in preserving kidneys for successful transplantation, including acceptable post-transplant renal function.Superiority: All dogs survived after kidney storage for 48-72 hours in BELZER UW-CSS, compared to 0% survival after 72 hours in ECS and 80% survival after 48 hours in ECS. Initial post-transplant renal function (serum creatinine) was better with BELZER UW-CSS.
    LiverEquivalence/superiority to ECS in extending preservation time and demonstrating comparable or improved post-transplant liver function.Superiority: Mean preservation time significantly longer (10.39 hours vs. 5.53 hours for ECS, p<0.01). Lower SGOT and SGPT on Day 1. Lower alkaline phosphatase at Day 7. Lower retransplantation rate (10 vs. 19 for ECS). Lower incidence of hepatic artery thrombosis (3 vs. 7 for ECS).
    PancreasEquivalence to ECS in post-transplant pancreas function, with potential for extended preservation time.Equivalence: Mean preservation time significantly longer (8.7 hours vs. 3.7 hours for ECS). No statistically significant differences in Day 1 serum amylase, urinary amylase, or blood glucose. Overall post-operative amylase levels not significantly different.

    2. Sample Sizes Used for the Test Set and Data Provenance

    • Kidney (Preclinical Data):

      • Sample Size: Not explicitly stated, described as a "dog transplant model."
      • Data Provenance: Preclinical animal study.

    • Liver (Clinical Data):

      • Test Set (BELZER UW-CSS): 122 livers
      • Control/Comparator Set (ECS): 126 livers
      • Data Provenance:
        • BELZER UW-CSS: Prospective clinical study, potentially multi-institutional (donor and recipient selection followed requirements established by "respective institutions").
        • ECS: Retrospective clinical data.

    • Pancreas (Clinical Data):

      • Test Set (BELZER UW-CSS): 9 grafts
      • Control/Comparator Set (ECS): 6 grafts
      • Data Provenance:
        • BELZER UW-CSS: Prospective clinical study.
        • ECS: Retrospective clinical data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable based on the provided text. This study involves clinical outcomes and laboratory measurements, not expert review of images or diagnoses. The "ground truth" is derived from physiological measurements and clinical events (e.g., survival, retransplantation, laboratory values).

    4. Adjudication Method for the Test Set

    Not applicable based on the provided text. This involves objective clinical and laboratory measurements, not subjective evaluations requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC study was not done. The study design is a comparison of organ preservation solutions based on clinical outcomes and laboratory markers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Not applicable. This is a medical device (a solution) used during a surgical procedure, not an AI algorithm.

    7. The Type of Ground Truth Used

    • Kidney: Dog survival rates, initial post-transplant renal function (serum creatinine values).
    • Liver: Post-transplant graft function assessed by selected clinical laboratory variables (SGOT, SGPT, alkaline phosphatase, total bilirubin, prothrombin time and partial thromboplastin time), retransplantation rates, deaths, incidence of hepatic artery thrombosis.
    • Pancreas: Post-transplant graft function assessed by serum and urinary amylase values, and blood glucose levels.

    These are all outcomes data and laboratory data/physiological markers.

    8. The Sample Size for the Training Set

    Not applicable. This is a medical device (a solution), not a machine learning model that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for this type of device.

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